everolimus To prevent organ rejection in liver transplant patients FDA approved it 2/20/13 Novo Nordisk A/S (Bagsvaerd, Denmark) Tresiba and Ryzodeg Insulin degludec and insulin degludec/insulin aspart Diabetes Received a complete response letter from the FDA on its NDAs 2/13/13 Pfizer Inc. (New York) Lyrica Pregabalin capsules CV Refractory partial onset seizures in epilepsy Phase III data showed it was as effective as levetiracetam 2/22/13 Sanofi Pasteur (Lyon, France) Hexyon/Hexacima 6-in-1

Nuvo Research Inc., of Mississauga, Ontario, said the FDA issued a complete response letter to Mallinckrodt Inc., of Dublin, Ireland, the pharmaceuticals business of Covidien, for Pennsaid (diclofenac sodium topical solution 2 percent

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA issued a second complete response letter regarding a supplemental new drug application for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome

received a complete response letter from the FDA for its Heplisav hepatitis B vaccine

The company received a complete response letter in May 2012, which cited chemistry, manufacturing and control issues

The original NDA was submitted in March 2009, followed by a complete response letter in April 2010

The FDA's complete response letter (CRL) for its Heplisav hepatitis B vaccine was no surprise to Dynavax Technologies Corp., of Berkeley, Calif., as it had extensive behind-the-scenes conversations with the FDA between the November advisory committee meeting and the CRL issued over the weekend

Ablynx NV, of Ghent, Belgium, reported efficacy and safety data for its anti-IL-6R nanobody, ALX-0061, at the 24-week final analysis of the Phase II part of a Phase I/II study in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. The Phase II data showed ACR20, ACR50 and ACR70 scores of up to 100 percent, 75 percent and 63 percent, respectively, for patients who were consistently dosed at 3mg/kg Q4W over 24 weeks. At all doses tested, ALX

Although the committee voted 8-4 in favor of approval of those two products, after which Copenhagen, Denmark-based Novo would be required to conduct a postmarketing trial assessing cardiovascular safety, the FDA opted for a complete response letter instead

extended-release capsule formulation of carbidopa-levodopa Parkinson's disease FDA issued a complete response letter 1/23/13 NuPathe Inc. (Conshohocken, Pa.) Zecuity Sumatriptan iontophoretic transdermal system Migraine FDA approved it for the acute treatment of migraine with or without aura 1/22/13 DIABETES Furiex Pharmaceuticals Inc. (Morrisville, N.C.) and Takeda Pharmaceuticals Co

The FDA classified the resubmission as a complete, Class 1 response to its October 2012 complete response letter and set a PDUFA date of March 31

Novo Nordisk A/S, of Bagsvaerd, Denmark, received a complete response letter (CRL) from the FDA on its new drug applications (NDA) for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial

That trial was requested by the FDA in its complete response letter the first time the drug went up for approval in the U.S., in 2010. (See BioWorld Today, March 8, 2010, and May 5, 2010.) Genzyme Inc.'s fresolimumab and Eli Lilly and Co.'s LY2382770, which are both in early phases of development, also go after TGF-beta, which is a key driver of fibrosis

received an FDA complete response letter for Ampligen for chronic fatigue syndrome

A late-stage change in clinical direction and the use of a trial placebo that turned out also to be a treatment in chronic fatigue syndrome (CFS) may have hobbled Hemispherx Bioscience Inc.'s regulatory efforts with Ampligen (rintatolimod), the Toll-like receptor 3 modulator that was hit with a complete response letter (CRL) earlier this month

Hemispherx Biopharma Inc.'s complete response letter from the FDA in the wake of a negative advisory panel review of Ampligen for chronic fatigue syndrome (CFS) left the company weighing its chances of success in appealing the decision, and left patients without options

Meanwhile, the FDA is reviewing the supplemental biologics license application for Sanofi's Lemtrada (alemtuzumab), which yielded impressive disability data in MS last year against Rebif as an active comparator. (See BioWorld Today, April 25, 2012.) The Opexa deal comes nearly two years after Merck Serono bailed on oral MS candidate cladribine rather than embark on a new clinical program as requested in an FDA complete response letter. (See BioWorld Today, March 3, 2011, and June 23, 2011

In April, the FDA – not for the first time – dropped a complete response letter on Takeda, asking for more data despite a sizeable Phase III package. (See BioWorld Today, April 27, 2012.) That package included results, first reported in 2008, from five Phase III studies with alogliptin that enrolled 2,000 patients in 220 centers worldwide

MAP's Levadex, an orally inhaled formulation of the intravenous migraine drug dihydroergotamine (DHE), is under FDA review in acute migraine following a complete response letter (CRL